KR20200012900A - Grip Accessories for Manual Injection Devices - Google Patents

Abstract

Grip accessory 300 for a manual injection device includes a housing 310 having a generally hollow body for supporting the manual injection device therein. The housing includes a distal portion 330 comprising a first opening into which the manual injection device can be inserted, a proximal portion 320 including a second opening through which the needle of the manual injection device extends, and proximal The portion includes a skin contact surface at the proximal end of the device. The intermediate portion 340 extends between the proximal and distal portions, and guide means for guiding the plunger rod of the injection device during the delivery of the injection liquid are provided on the inner surface of the distal portion.

Description

Grip Accessories for Manual Injection Devices

The present invention relates to an accessory for a manual injection device, in particular a grip accessory for use with a manual injection device.

To reduce the risk of accidental needle sticks that can cause the transmission of blood borne pathogens, needle safety devices are typically combined with syringes when performing injections. Used. In particular, these needle safety devices are often needed to protect Health Care Providers, such as nurses who frequently use syringes to administer injections to patients. These needle safety devices can typically be classified into one of two types: (1) Passive devices that automatically cover the needle after injection, without requiring additional steps from the user to activate the device. device), and (2) a device requiring additional steps by the user to activate the needle safety feature. Passive needle safety devices are generally considered to be superior in their ability to protect the user from accidental needle punctures, because for various reasons the user may not be able to take the additional action required to activate the non-passive device. Health authorities and health care systems often require the use of needle safety devices in environments where HCPs perform injections. In addition, the needle safety device may risk the risk of injury, infection, and transmission of blood-borne pathogens to patients, family members, caregivers, and anyone who may come into contact with the injection device in the course of performing the injection and discarding the used syringe. Preferred for self- and caregiver-administered injections to mitigate.

A commonly used example of a needle safety device is the UltraSafe family of devices manufactured by Becton Dickinson. Ultrasafe consists of a spring and two plastic components assembled to a syringe, along with a custom plunger rod. Upon completion of the injection, the plunger rod engages a latch on the ultrasafe housing component to activate the device and allow the spring to extend one of the housing components onto the needle and lock in place. One example of an ultrasafe device is shown in FIGS. 1A and 1B. 1A shows the device in a ready state before an injection is made. 1B shows the device in a safe used state after the injection is completed.

2 illustrates a typical usage description for using an ultrasafe device. As can be seen in FIG. 2, the steps for using ultrasafe are essentially the same as for performing injection by a bare syringe. Pinching the skin (shown in step (A) of FIG. 2) and injecting it at a 45 degree angle limits the depth of injection and prevents the injection into muscle (too deep) or intradermally (into the skin). It is essential to ensure that it is provided subcutaneously. Injecting too shallowly or too deep can affect pharmacokinetics (PK) and pharmacodynamics (PD) for drugs intended for subcutaneous injection.

As shown in FIG. 2, the steps for proper use of a syringe to achieve subcutaneous injection are actually quite complex, and changes between users may cause differences in injection depth, which may affect the efficacy of the drug. Can be. HCPs, such as nurses, are very familiar and skilled in the procedures for performing injection by syringe. However, the technique differs between nurses, which can affect PK and PD. In addition, injection techniques require the use of two hands, one hand grasping and one hand injecting, making it difficult for a nurse to perform an injection on a difficult patient, such as a pediatric patient who can move during the injection. In addition, even when nurses are comfortable to use syringes, patients are often afraid of syringes and needles, and injections often lead to an uncomfortable patient experience.

Syringes are particularly difficult for use by patients and caregivers, not only because of the complexity of the steps of use (as described above), but because syringes with exposed needles also tend to cause anxiety in the patient.

Accordingly, there is a need to develop a needle safety device that is inexpensive, simple and easy to use, can be operated with one hand, creates a consistent needle insertion depth, and reduces injection jitter. Ideally, the safety device would provide an intermediate form between the syringe or safety device (such as ultrasafe) and a full automatic injector.

In a first aspect of the invention, a grip accessory for a manual injection device is disclosed, the grip accessory comprising a housing comprising a generally hollow body configured to support the manual injection device therein, wherein the housing is A distal portion comprising a first opening into which the manual injection device can be inserted; A proximal portion comprising a second opening through which a needle of a manual injection device extends, the proximal portion comprising a skin contact surface at the proximal end of the device; And an intermediate portion extending between the proximal portion and the distal portion. The skin contacting surface of the grip accessory device may serve to limit the insertion depth of the needle of the injection device. For example, the grip accessory can be configured to limit the needle insertion depth for subcutaneous, subdermal, intramuscular injections, and the like.

In order to minimize the complexity of manufacturing and assembling the grip accessories according to the invention, some embodiments of the grip accessories are preferably for example injection molding or additive manufacturing processes (eg 3D printing). It is formed as a single piece. In some embodiments of the invention, the grip accessory does not include moving parts.

In some embodiments, the distal portion may include diametrically opposed tongues, two tongues with cut-outs between the tongues. The tongues may include gripping surfaces, eg, ridged surface region, on the outer surfaces of the tongues. The tongues may also include fixing means on the inner surfaces of the tongues for securing the injection device between the tongues. In other embodiments, the distal portion may be a substantially tubular body that surrounds the distal end of the injection device (not limited to having a circular cross section).

The grip accessories according to the invention may be provided with an injection device therein. The injection device may be a conventional syringe or it may be an injection safety device, for example an injection safety device comprising a syringe housing for holding a syringe body; A safety shield, which is movably mounted relative to the syringe housing between a retracted position in which the proximal end of the needle extends from the proximal end of the safety shield and an extended position in which the safety shield extends above the proximal end of the needle. Safety shield; A biasing device for biasing the shield towards its extended position; And a releasable locking mechanism for holding the sleeve in its retracted position.

The grip accessory may be configured to support the injection device in a generally hollow body such that the proximal tip of the needle of the injection device extends a predetermined distance D ₁ past the plane P defined by the skin contact surface. Can be. The distance D ₁ may be within one or more of the following ranges: 3 mm to 12 mm; 4 mm to 10 mm; And 5 mm to 8 mm. Preferably, the distance D ₁ is greater than the second distance D ₂ , which is the shortest distance in the plane P between the needle and the outer edge of the proximal portion, preferably the outer edge of the flange. The distance D ₁ may be less than the total distance D ₃ between the proximal end of the needle and the point at which the needle is connected to the syringe body.

In some embodiments, the support structure may secure the syringe in the housing such that the needle extends by a fixed distance D ₁ from the plane P. In another embodiment, the support structure can secure the safety device in the housing. In these embodiments, the safety device is fixedly mounted in the housing such that the syringe extends from the plane P by a fixed distance D ₁ in preparation for injection.

The support structure for supporting the injection device in the housing may include a recess for restraining the flange of the injection device, such as the flange of the syringe or the flange of the safety device. Ramped surfaces for guiding the flanges of the injection device into the recesses may be provided distal of the recesses. The housing may further comprise at least one rib, preferably extending longitudinally along the inner surface of the housing, to limit or prevent rotation and / or lateral movement of the manual injection device.

In some embodiments, the grip accessory can include a flange at the proximal end of the housing that at least partially surrounds the second opening and provides a skin contact surface at the proximal end of the device. The flange may be formed as a flared opening and extend radially outward from the housing. The flange may comprise a substantially circular footprint (the footprint is a cross-sectional area bounded by the outer circumference of the flange). Alternatively, the flange may have an elongate footprint, ie oval or rectangular. The ovoid footprint preferably comprises two mutually opposite parallel lines connected by two circular arcs. By providing parallel sides opposite one another, the tendency of the device to roll on flat surfaces is eliminated. Of course, oval ovoid footprints are also within the scope of the present invention. The flange can help limit the insertion angle of the needle. The flange can also help further control the insertion depth by increasing the surface area in contact with the skin and limiting the extent to which the skin contact surface can be pressed into the injection site. The flange can have a minimum outer dimension (ie, the shortest distance between two opposite sides of the flange) of at least 8 mm, more preferably at least 15 mm, most preferably at least 25 mm.

An inner sheath may be provided at the proximal end of the housing. The inner sheath may be cylindrical and may have a narrow diameter relative to the outer diameter of the skin contact surface. For example, the inner diameter of the sheath can be at least 8 mm. The inner sheath can provide at least two advantages. It may help to stabilize the proximal tip of the injection device by limiting lateral movement. It may also serve to avoid needle stick injuries by limiting the size of the opening in the proximal end of the device to prevent the user from inserting his or her fingers into the housing after the injection is complete. Advantageously, the inner sheath also restricts the user from seeing the proximal end of the device, shielding the needle from being visible to the user to reduce injection anxiety.

In some embodiments, the aperture at the proximal end of the housing may have a minimum outer dimension of at least 12 mm, more preferably at least 15 mm, most preferably at least 18 mm.

The skin contact surface has an outer radius R ₁ . Radius R ₁ may be selected to help limit the insertion depth of the needle. For example, the radius R ₁ is at least 6 mm; At least 8 mm; It may be at least 9 mm. Preferably, the ratio of R ₁ : D ₁ is at least 1: 1; 1.5: 1 or more; Or 2: 1 or greater. This helps to limit the insertion depth of the needle to 90 degrees with respect to the surface of the skin at the injection site.

The generally tubular hollow body for receiving an injection device may comprise a substantially square or circular cross section. Alternatively, the housing, and in particular the middle part, may comprise an elongated cross section. The cross section serves to orient the device comfortably in the palm of the user when a fist grip is used. The long cross section also prevents the device from rolling on a flat surface. The cross section is the cross section defined in the longitudinal axis A of the housing, ie the plane perpendicular to the axis in which the piston rod moves along it during the injection of the drug.

In some embodiments, the middle portion of the grip accessory has an outer circumference of the proximal portion and / or an outer circumference of the distal portion, such as an outer circumference smaller than the flange. This narrower middle portion can help the orientation of the grip in the user's hand and prevent the user's hand from protruding past the plane P, which will change the depth of injection achieved.

Changes in the maximum outer dimension between the middle and proximal portions can also provide a ledge or support surface that allows the device to be gripped with a conventional or dart grip.

The distal portion of the housing may include at least one indent for supporting the user's finger.

The distal portion may include at least one opening or cutout configured to provide viewing of at least a portion of the manual injection device. Openings or cutouts also reduce the range of rims that the plunger may be caught on as it nears the end of the injection. In a preferred embodiment, the distal portion of the housing has a long cross section, with openings or cutouts provided on the long sides. This ensures that the risk of the plunger being caught on the distal edge of the five housings is reduced. The cutout may also expose at least part of the bung of the syringe or part of the locking mechanism of the syringe safety device. This may allow the user to inspect the distal end of the syringe prior to injection to confirm that the syringe barrel is full.

In addition to or as an alternative to the cutout, the generally tubular housing may include at least one window to allow inspection of the syringe barrel. The window may be provided on the intermediate portion and extends along all or part of the barrel of the syringe mounted in the housing. If the housing comprises a long cross section, the window is preferably provided on the long side of the housing. This ensures that the window is usefully oriented when the device is seated in the palm of the user. Preferably, two radially opposite windows are provided on the sides opposite to each other of the housing in order to allow light transmission and better visibility. A window along the body of the tubular housing may allow a user to examine the drug prior to injection to check the contents of the syringe for particles or discoloration of the drug.

The grip accessory according to the invention can be dimensioned for use by one hand. For example, the length of the middle portion can be within one or more of the following ranges: 20 mm to 120 mm; 30 mm to 100 mm; 40 mm to 90 mm; And 50 mm to 70 mm. The total length of the grip accessory from the proximal end of the proximal portion to the distal end of the distal portion may be within one or more of the following ranges: 40 mm to 120 mm; 50 mm to 100 mm; 60 mm to 110 mm; And 70 mm to 100 mm.

In some embodiments, the manual injection device further comprises a plunger, wherein the plunger moves the plunger to which an actuation force can be applied to move the plunger along the longitudinal axis to deliver a dose of medicament. At its distal end.

The plunger has a length extending from its proximal end to its distal end, which may be from 50 mm to 100 mm, more preferably from 60 mm to 90 mm, most preferably from 60 mm to 80 mm.

In some embodiments, the grip accessory at least partially surrounds the releasable locking mechanism. This prevents the user from accidentally releasing the releasable locking mechanism as the user handles the device.

The releasable locking mechanism includes at least one deflectable latching arm movable from a first position that allows the safety shield to remain in its retracted position and a second position that no longer holds the safety shield to its retracted position. ) May be included. The plunger may be configured to move the at least one flexible latch arm from its first position to its second position.

In some embodiments, the actuating surface moves the flexible latch arm from the first position to the second position. In another embodiment, the plunger may further comprise an unlatching portion proximal to the operating surface, configured to move the flexible latch arm to its second position.

The unlatching portion may comprise a disc or flange extending from the plunger rod, proximal to the actuation surface, which may be molded integrally with the plunger rod.

In some embodiments, the distal portion of the housing may further comprise guide means for guiding the unlatching portion of the plunger to a position where it unlatches the releasable locking mechanism.

The guide means may comprise a plurality of ribs extending longitudinally along the inner surface of the housing body defining a channel for receiving the unlatching portion and preventing lateral movement of the unlatching portion.

At least one of the plurality of ribs may include a curved distal surface for guiding the unlatching portion into the channel.

According to a second aspect of the invention, there is provided a grip accessory for a manual injection device, wherein the grip accessory is a housing comprising a generally hollow body for supporting the manual injection device therein, wherein the manual injection device is to be inserted therein. A housing comprising a distal portion comprising a first opening that can be opened; A housing configured to support a manual injection device therein, the housing comprising: a proximal portion including a skin contact surface at the proximal end of the device including a second opening through which the needle of the manual injection device extends; An intermediate portion extending between the proximal portion and the distal portion; And a guide means on the inner surface of the distal portion for guiding the plunger rod of the injection device during the delivery of the injection liquid.

The guide means may comprise at least one longitudinal rib extending along the inner surface of the housing to limit the lateral movement of the plunger rod of the injection device. Preferably, the guide means comprises a plurality of longitudinal ribs. The ribs may extend proximally from the distal end of the housing. The plurality of ribs may define a channel in the distal portion of the housing, with the plunger rod moving along the channel.

In some embodiments, the plurality of ribs includes a curved distal face for guiding the plunger rod into the channel and preventing the plunger rod from being caught on the distal end of the grip accessory. The distal face of the ribs can also be inclined to achieve this goal. Preferably, the curved or sloped ribs provide a flared opening in the channel for guiding the unlatching surface into the channel.

The grip accessory can support an injection device such as a conventional syringe or safety device therein. The safety device or manual injection device includes a syringe body having a needle at the proximal end; A syringe sheath supporting the syringe body therein; A safety shield, comprising: a safety shield movable relative to the syringe sheath between a retracted position in which the needle extends from the proximal end of the safety shield and an extended position in which the safety shield extends over the needle; Convenience elements for biasing the shield towards its extended position; A releasable locking mechanism for maintaining the syringe sheath in its retracted position against the bias of the biasing element, the first position preventing the movement of the syringe shield relative to the syringe sheath and the safety shield relative to the syringe sheath. A releasable locking mechanism that is movable from a second position that does not prevent movement; And a plunger rod extending from the distal end of the syringe body to deliver a dose of drug through the needle, the plunger having a releasable locking mechanism as the plunger rod is moved proximally to deliver a dose of drug. And a plunger rod, which includes an unlocking component for moving from its locked position to its unlocked position.

The releasable locking mechanism may include at least one deflectable latching arm movable from a first position that allows the safety shield to remain in its retracted position and a second position that no longer holds the safety shield to its retracted position. And the plunger includes a latching element configured to move the at least one flexible latch arm from its first position to its second position. The releasable locking mechanism can be disposed in a channel formed by the plurality of ribs.

The unlatching element provided on the plunger may be a flange or disc extending from the plunger rod. Preferably, the channel is dimensioned to receive the latching element and to prevent lateral movement of the latching element with respect to the housing.

Additionally or alternatively, the plunger rod may include at its distal end an actuation surface for receiving the thumb or finger of the user when delivering the injection, the channel receiving the actuation surface and the side of the actuation surface relative to the housing. It is dimensioned to prevent directional movement.

In a third aspect of the invention, a manual injection device is provided, the manual injection device comprising: a syringe housing for holding a syringe body having a discharge nozzle; a safety shield, wherein the retracted position and the safety shield extend over the needle A safety shield movable between extended positions; A convenience device for biasing the safety shield to its extended position; A releasable locking mechanism for maintaining the safety shield in its retracted position when in the locked position and allowing the safety shield to move to its extended position under the influence of the convenience device when in the unlocked position; And a plunger for delivering a dose of drug through the discharge nozzle, the plunger being movable from the distal position to the proximal position along the longitudinal axis, wherein the plunger moves the plunger in the longitudinal axis to deliver a dose of drug. An operating surface at the distal end of the plunger, to which an actuation force for moving along may be applied; And a latching element proximal to the operating surface, configured to unlock the releasable locking mechanism to allow the safety shield to move to its extended position.

The releasable locking mechanism may include at least one deflectable latching arm movable from a first position that allows the safety shield to remain in its retracted position and a second position that no longer holds the safety shield to its retracted position. have. The plunger may be configured to move at least one flexible latch arm from its first position to its second position when it is moved from its distal position to its proximal position.

The unlatching element may be an annular projection, a flange or a disk extending from the body of the plunger and spaced apart from the working surface of the plunger.

In some embodiments, the plunger may provide an unlatching surface at the change in dimension of the plunger rod. In this case, the plunger rod includes a distal portion having a first cross sectional diameter and a proximal portion having a second cross sectional diameter. The first cross sectional diameter may be greater than the second cross sectional diameter. At the point where the proximal portion meets the distal portion, a support surface is provided that can act as an unlatching surface for moving the releasable locking mechanism to its second position.

In both cases, the unlatching portion may comprise a curved proximal surface or a flat proximal surface.

In any of the grip accessories according to the invention, a retractable sheath can be provided at the proximal end of the device, which extends from the retractable sheath and the extended position where the sheath extends above the proximal end of the discharge nozzle. It is movable between the retracted positions. Preferably, the retractable sheath is retractable to a position whose proximal end does not extend from the plane P defined by the skin contact surface.

By referring to the following description of exemplary embodiments of the invention taken in conjunction with the accompanying drawings, the above mentioned and other features and advantages of the invention will be better understood.
1A and 1B show an ultrasafe injection device in an injection ready state (FIG. 1A) and a safe, post-injection state (FIG. 1B).
2A-2D illustrate exemplary usage instructions for use of the injection device of FIG. 1.
3 shows the proximal end of a grip accessory according to an embodiment of the invention.
4 illustrates a grip accessory in accordance with an exemplary embodiment of the present invention incorporating the injection device of FIG. 1.
5A-5C illustrate the grip accessory of FIG. 4 in use.
6a to 6d show an alternative embodiment of a grip accessory according to the invention.
7 shows another embodiment of a grip accessory according to the invention.

1A and 1B show a manual injection device 100 suitable for use with the grip accessory according to the present invention. Injection device 100 includes a syringe 110 that extends from the proximal end to the open distal end, including the needle 130. The open distal end of the syringe is sealed by a stopper 140. A needle cap 190 is optionally provided to enclose the needle 130.

The syringe 110 is secured in the syringe sheath 120 by the syringe locking element 125. The syringe locking element 125 may include abutment surfaces 121, 122 opposite each other in the radial direction in which the flange of the standard syringe is constrained therebetween. The restraint of the flange between the abutment surfaces 121, 122 prevents the movement of the syringe 110 relative to the syringe sheath 120.

The syringe sheath 120 includes an open distal end 101 through which the syringe 110 can be inserted, and an open proximal end from which the needle 130 extends from when the syringe 110 is secured within the sheath 120. 102). Safety shield 150 is movably mounted relative to syringe sheath 120. Safety shield 150 has a retracted position (shown in FIG. 1A) in which needle 130 extends beyond the proximal end of the safety shield, and a safety shield extends beyond the proximal end of the needle (shown in FIG. 1B). It is movable between extended positions. In the second position shown in FIG. 1B, the needle 130 is covered by the safety shield 150 to shield the user from the needle and prevent accidental needle-stick injuries.

To allow the user to grip the injection device 100 with a conventional dart grip (as shown in FIG. 2), the safety shield 150 includes a flange 155 at or toward its distal end. do. The flange 155 shown in FIG. 1 extends from the safety shield 150. However, those skilled in the art will appreciate that flange 155 may be provided on syringe sheath 120.

Safety shield 150 is biased by convenience element 160 to its extended position relative to syringe sheath 120 (shown in FIG. 1B). The convenience element 160 shown in FIGS. 1A and 1B is provided between the syringe sheath 120 and the safety shield 150 such that the safety shield 150 is biased in its extended position proximal to the syringe sheath 120. Take the form of coil springs arranged.

Releasable locking mechanism 180 maintains safety shield 150 in its retracted position relative to syringe sheath 120. The locking mechanism 180 is in a locked position (FIG. 1A) where the locking mechanism 180 prevents the safety shield 150 from moving relative to the syringe sheath 120, and the locking mechanism 180 is in the syringe sheath 120. It is movable between unlocked positions that no longer prevents movement of the safety shield 150 relative to it. Once the locking mechanism is moved to its unlocked position, the safety shield 150 moves to its extended position under the influence of the coil spring 160 (FIG. 1B).

In the apparatus shown in FIGS. 1A and 1B, the locking mechanism 180 between the safety shield 150 and the syringe sheath 120 is a pair of flexible latch arms 181 provided on the safety shield 150. Taking shape, it engages an opposing latching surface 183 on the syringe sheath 120. The flexible latch arms 181 are biased into a first position where they engage their respective latching surfaces 183, preventing the proximal movement of the safety shield 150 relative to the syringe sheath 120. When the flexible latch arm 181 is moved against this biasing force, the latch arms 181 are disengaged from their respective latching surfaces 183, so that the safety shield 150 against the syringe sheath 120 Allow for proximal movement.

The latch arm 181 is configured to be moved from the first position to the second position by the custom plunger rod 170. The plunger rod 170 includes an elongate member, the elongate member engaging the stopper 140 at its proximal end and moving the stopper proximally along the longitudinal axis of the syringe body to produce a dose of a constant dose through the needle 130. Configured to deliver the drug. At its distal end or towards its distal end, the plunger 170 is provided with an actuating surface 175 on which a user can place a thumb or finger thereon to drive the plunger proximally to deliver the injection. do. As the plunger rod approaches or reaches the end of its movement within the syringe body, the actuating surface 175 of the plunger rod 170 outwards the flexible latch arm 181 so that they latch on the syringe sheath 120. Deflect to a position no longer engaged with surface 183. Thus, the locking mechanism is released at the end of the scan and the safety shield 150 moves to its extended position.

Although not shown in the accompanying drawings, the manual injection device of FIGS. 1A and 1B may further include a safety lock for locking the safety shield 150 to its extended position after the injection is complete.

The grip accessory for use with the injection device of FIGS. 1 and 2 will now be described with reference to FIGS. 3 to 7.

As shown in FIG. 3, grip accessory 300 includes a housing 310 having a generally hollow body for receiving an injection device 100. The injection device 100 is supported in the housing such that the needle 130 extends a predetermined distance D ₁ past the skin contact surface surrounding the opening at the proximal end of the housing. During injection, the maximum insertion depth of the needle is limited by the skin contact surface 367 which comes into contact with the injection site. This helps to control the insertion depth of the needle without the needle picking up the skin (as shown in FIG. 2) and inserting the needle at an angle of 45 degrees relative to the injection site. Instead, the needle can be inserted at an angle of 90 degrees to the full range allowed by the grip accessory. The range in which the needle extends from the plane P defined by the skin contact surface may be selected depending on the type of injection desired (subcutaneous, intramuscular, etc.). For example, for subcutaneous injection, the distance D ₁ may be 3 mm to 12 mm, more preferably 4 mm to 10 mm, more preferably 5 mm to 8 mm.

The grip accessory of the present invention may take various forms. As shown in FIG. 4, grip accessory 300 includes a housing 310 having a distal portion 330, a proximal portion 320, and an intermediate portion 340 extending between the proximal and distal portions. . The distal portion 330 of the housing 310 generally includes a distal opening 335 to allow insertion of the injection device into the hollow body. Proximally to the distal opening, the housing 310 includes two recesses 352 that restrain the flange 155 of the safety shield 150 and secure the injection device 100 within the housing. Once the flange 155 is constrained in the recess 352, the syringe 110 and needle 130 are secured relative to the grip accessory 300 until the locking mechanism 180 is released.

To facilitate the insertion of the injection device 100 into the housing 310, a ramped surface (not shown) may be provided on the interior of the housing 310 directly distal of the recess 352. This guides the flange 155 of the injection device 100 into the recess 352. Once the flange 155 moves on a ramp (not shown) and snaps into the recess 352, the injection device 100 is locked into the grip accessory 300. In some embodiments, but not all, the housing further includes a rib on the interior of the housing to prevent lateral and rotational movement of the injection device 100 within the housing 310.

As shown in FIG. 4, the distal portion 330 of the housing 310 at least locks the locking mechanism 180 of the injection device 100 to provide a shield around the locking mechanism 180 of the injection device 100. May be partially enclosed. The shield prevents the user's hand from coming into direct contact with the locking mechanism 180 to inadvertently move the unlocking mechanism 180 and activating the needle shield before the injection is complete. To allow a user to see the distal end of the injection device 100, the distal portion 330 may include one or more cutouts 380. By providing a cutout 380 at the distal end of the housing, the risk of the plunger being caught at the distal end of the housing is minimized. To further mitigate this risk, the plunger may include a flexible latching component that can bend upon contact with a relatively rigid housing. This will be described later in more detail.

In some embodiments, housing 310 also includes at least one, preferably two or more indentations 385 to provide improved gripping of a user's finger. As shown in FIG. 3, indentation 385 may be provided at or near the engagement of distal portion 330 and intermediate portion 340. Indentation 385 may provide a support surface 387 for the user's finger, which may be used to facilitate conventional dart grip of accessory 300 (see FIG. 2). Alternatively, indentation 385 may be provided on distal portion 330. In either case, indentation 385 is used to ensure the correctness of a user's fingers when the device is used with a fist grip (with the grip accessory positioned within the palm of the user's hand and the thumb positioned to actuate the plunger rod 170). And facilitate a comfortable deployment, or provide a support surface for a conventional dart grip (shown in FIG. 2).

The middle portion 340 extends between the proximal portion 320 and the distal portion 330 of the housing. Middle portion 340 is preferably narrower than proximal portion 320 and distal portion 330. It has a generally tubular form that surrounds substantially all of the syringe sheath 120 and the safety shield 150 of the injection device (before the safety shield 150 extends). The narrower middle portion 340 helps the user grip the device when the fist grip is used. It may also provide a support surface for the dart grip, as described above.

The generally hollow housing 310 of the grip accessory can take a variety of forms. In some embodiments, as shown in FIG. 4, the housing 310 has a generally long cross section, the cross section perpendicular to the longitudinal axis A of the housing, ie the axis through which the piston rod moves along during the injection of the drug. Defined within one plane. The long cross section may be oval, oval, rectangular or any other long shape. Advantageously, the long cross section allows the grip accessory to rest comfortably in the palm of the user (when the fist grip is used).

In some embodiments, as shown in FIG. 4, the middle portion 340 of the housing 310 includes a window 395. The window 395 may be located on the long side of the housing 310 (defined as the long side of the long cross section described above). Because the cross section of the middle portion is long, the grip accessory naturally sits in the palm of the user with the window 395 facing outward. Two windows 395 may be provided, one on each side of the housing 310.

In some embodiments, with continued reference to FIG. 4, the proximal portion 320 of the housing 310 includes a flared opening that provides a flange 365 surrounding the proximal opening 360. The flange 365 provides a skin contact surface 367 disposed against the skin at the injection site to control the insertion depth of the needle 130. The flange 365 also prevents a user from inadvertently placing their fingers between the grip accessory and the injection site, which may limit or entirely prevent proper insertion of the needle into the injection site.

The outer radius of the skin contacting surface may be selected to help limit the insertion angle of the needle 130. For example, the outer radius R ₁ of the skin contact surface 367 can approximate or exceed the length D ₁ of the needle extending from the housing. Preferably, the minimum outer radius R ₁ is at least 3 mm, more preferably at least 5 mm and even more preferably at least 8 mm.

In addition to the above, the flange 365 can advantageously increase the surface area of the housing in contact with the injection site, thereby reducing pressure and increasing comfort for the user. The increased surface area of the flange also helps the user position the proximal end of the device flat (with the needle at 90 degrees) relative to the injection site. However, one skilled in the art will recognize that flange 365 is not essential. An embodiment of a grip accessory according to the invention that does not include a flange 365 will be described in more detail below with reference to FIGS. 6A-6D.

In some embodiments, as shown in FIG. 4, an inner sheath 370 may be provided within the circumference of the flange 365. The inner sheath 370 effectively reduces the diameter of the proximal opening 360 through which the needle 130 of the injection device 100 extends. Sheath 370 provides several advantages. Sheath 370 supports the syringe against radial lateral movement to improve the stability of the syringe in the device. It may also help to prevent needle puncture injuries after completion of the injection device because the reduced diameter of the proximal opening 360 is sized to prevent the finger from being inserted into the housing 310. The reduced diameter of the medial sheath also limits the visibility of the needle and helps to reduce injection anxiety in a significant proportion of people with needle phobia. Finally, the sheath 370 can reduce skin swelling from the injection site into the proximal end of the device. Since skin swelling affects the total insertion depth of the needle, this may provide a significant advantage in some embodiments. Preferably, the inner sheath 370 does not extend beyond the plane defined by the skin contacting surface of the housing 310.

In some embodiments (but not all), in particular with reference to FIG. 4, the grip accessory may be provided with a modified plunger 270. The deformed plunger 270 has an actuating surface 275 for receiving a thumb or finger of the user to deliver the injection and an actuating surface for unlocking the releasable locking mechanism 180 of the injection device 100. And an unlocking component 280 proximal to 275 and spaced apart from the operating surface. Unlocking component 280 deflects latch arm 181 away from their rest position where they engage latching surface 183 on syringe sheath 120 in a manner similar to operating surface 175 described above. Unlock the unlockable locking mechanism 180. The unlocking component may take the form of a disk 280 extending around the plunger rod, proximal to the operating surface 275. Preferably, disk 280 is formed of a flexible material that is more flexible than the main housing of the grip accessory. This allows the disk 280 to bend when the plunger comes into contact with the grip accessory housing in a slightly misaligned state during injection, preventing the plunger from being caught on the grip accessory housing before the injection is complete. Those skilled in the art will appreciate that a relatively flexible disk 280 may be provided in a number of ways. For example, the disc may be made of the same material as the grip accessory housing, but may have increased flexibility due to the reduced thickness (compared to the grip accessory housing). Disk 280 may also be made from a material having a lower Young's modulus, that is, a more flexible material in nature.

An advantage of the modified plunger 270 is that the working surface does not need to come into contact with the locking mechanism 180 to release the safety shield 150. Instead, the unlocking component 280 reaches the locking mechanism 180 to release the safety shield 150 due to its proximal position relative to the working surface. This means that the user's thumb / finger does not need to be in close proximity to the locking mechanism, thereby reducing the risk of the user's hands interfering with the locking mechanism and reducing the dexterity needed to use the device. Preferably, the distance between the working surface and the proximal surface of the unlocking component is at least 5 mm, at least 8 mm, at least 10 mm or at least 15 mm.

Of course, those skilled in the art will recognize that the modified plunger shown in FIG. 3 is one of many variations on the plunger rod that can be manufactured to achieve the above effect. For example, instead of using the actuating surface 275 and the disc-like unlocking component 280, the modified plunger instead includes a unitary configuration comprising an actuating surface at one end and an unlocking component at the other end. It can contain elements. In some embodiments, unlocking component 280 may include a curved or inclined proximal surface for biasing latch arm 181 as described above.

Now, the use of the grip accessory 300 will be described with reference to FIG. 5. In use, the grip accessory 300 incorporating the injection device 100 is gripped by the user with either a dart grip or a fist grip. The step shown in FIG. 5 shows the fist grip with the grip accessory 300 disposed in the palm of the user. However, those skilled in the art will understand that dart grips (as shown in FIG. 2) may also be used. The needle cap 190 is removed from the needle and the device is now ready for injection. The user places the grip accessory 300 relative to the injection site 10, with the needle at an angle of 90 degrees to the surface of the skin at the injection site 10 (see step (A) of FIG. 5). If the injection device is placed relative to the injection site in this way, as described above, the insertion depth of the needle is controlled. Once pressed against the site, the user then presses the plunger 170 (see step (B) of FIG. 5). The plunger 170 drives the stopper 140 toward the proximal end of the injection device to deliver a dose of drug through the needle 130. When the plunger 170 reaches the end of its movement within the syringe 110 (ie, when the stopper 140 reaches the proximal end of the syringe and cannot move further), the unlocking component 180 Disengages the latch arm 181 from the corresponding engagement surface 183, allowing the safety shield 150 to advance relative to the syringe sheath 120 under the influence of the coil spring 160. Since the safety shield is locked in place in the grip accessory 300 (by the flange 155 constrained in the recess 352), the syringe sheath 120 and the syringe are retracted within the grip accessory 300. (See step (C) of FIG. 5). The grip accessory is now safe to remove from the injection site 10, where the needle is shielded in the housing 310 of the grip accessory.

6A-6D illustrate alternative embodiments of grip accessories according to the present invention. As shown in FIG. 6A, the distal portion 511 of the grip accessory may include sidewalls opposite each other with cutouts 512 therebetween. In this embodiment, the flange 155 of the injection device 110 extends through the cutout 512 to allow a user to grip the injection device 110 directly. The embodiment shown in FIG. 6A also includes a ridged region 513 on the outer surface of the distal portion 511 to improve the grip of the user on the device. The proximal end 514 of the embodiment shown in FIG. 6A does not include a flared proximal end. Instead, the middle portion 515 and the proximal portion 514 have substantially the same cross section.

The embodiment shown in FIG. 6A is intended for use with a conventional dart grip. Since the embodiment shown in FIG. 6A is not intended to be used as a fist grip, the housing 510 does not include a long cross section that helps to seat the device in the palm of the user. Instead, the embodiment shown in FIG. 5A includes a substantially square cross section (with rounded corners).

The embodiment shown in FIG. 6B is generally similar to the embodiment described above with reference to FIG. 6A, except for the addition of flared proximal end 524. Ridged surfaces on the distal portion are also omitted from this embodiment.

The embodiment shown in FIG. 6C is also generally similar to the embodiment described above with reference to FIG. 6A, except that the cross section of the housing 530 is long.

The embodiment shown in FIG. 6D is the embodiment shown in FIG. 3, except that the distal end 541 of the housing 540 does not include a cutout, such as cutout 335 shown in FIG. 3. It is generally similar to. Instead, the distal portion 541 of the housing surrounds the locking mechanism 180 of the injection device 110, so that a user may unintentionally disengage the latch arm 181 from the latching surface 183 with their hands. Minimize. The embodiment shown in FIG. 6D also shows an alternative to the flared end 365 shown in the embodiment of FIG. 3. Instead of the flared opening as shown in FIG. 3, the housing 540 of FIG. 6D has a generally tubular profile with a narrower middle portion. This design may be particularly suitable for embodiments that do not include an additional unlocking component 280 (as described above) and instead rely on the operating surface 275 to unlock the releasable locking mechanism. .

Another embodiment of the grip accessory 600 according to the present invention is shown in FIG. 7. In this embodiment, the distal portion 630 of the housing extends to provide a grip portion at the distal end 630 of the grip accessory, rather than at the middle portion. This design allows for use of the fist-grip by one hand of the longer injection device, which allows the extended proximal portion 360 to be gripped in the palm of the user without damaging the locking mechanism 180 of the injection device 110. Because it can.

The embodiment shown in FIG. 7 also advantageously includes plunger rod guide means 670 for guiding the plunger rod 170 on its movement along the longitudinal axis of the injection device. The plunger rod guide includes a series of ribs 670 that prevent lateral movement of the unlocking component 280 relative to the housing. This ensures the alignment of the unlocking component 280 with the latch arm 181 and prevents failure of the unlocking mechanism 180 due to the unlocking component 280 being caught on the housing or other part of the locking mechanism. prevent.

Grip accessories according to the present invention are generally designed for use by one hand with either conventional dart grips or piste grips and are sized accordingly. For example, the total length of the grip accessory 300 (from the skin contact surface to the distal end of the distal portion) is preferably within one or more of the following ranges: 40 mm to 120 mm, 50 mm to 100 mm, 60 mm to 110 mm and 70 mm to 100 mm. The middle part of the grip accessory preferably has a total length within one or more of the following ranges: 20 mm to 120 mm, 30 mm to 90 mm and 50 mm to 70 mm. The plunger preferably has a total length within one or more of the following ranges so that the plunger can be operated with the device held in one hand: 50 mm to 100 mm, 60 mm to 90 mm and 60 mm to 80 mm .

Once the present disclosure is understood, those skilled in the art will recognize that the grip accessory of the present invention may be modified to accommodate a variety of different injection devices. While preferred embodiments of the invention have been described and illustrated herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be used in practicing the invention. The following claims define the scope of the present invention and it is intended that the devices and methods within the scope of these claims and their equivalents be embraced thereby.

Claims (19)

As a grip accessory for a manual injection device,
A housing comprising a generally hollow body for supporting a passive injection device therein, the housing comprising:
A distal portion comprising a first opening into which the manual injection device can be inserted;
A proximal portion comprising a second opening through which a needle of the passive injection device extends, the proximal portion comprising a skin contact surface at the proximal end of the device;
An intermediate portion extending between said proximal and distal portions; And
And a guide means on the inner surface of the distal portion for guiding a plunger rod of the injection device during the delivery of an injection. The grip accessory of claim 1, wherein the guide means comprises at least one longitudinal rib extending along an inner surface of the housing to limit lateral movement of the plunger rod of the injection device. The grip accessory of claim 2, wherein the guide means comprises a plurality of longitudinal ribs. The grip accessory of claim 3, wherein the plurality of ribs define a channel in the distal portion of the housing and the plunger rod moves along the channel. The grip accessory of claim 2, 3, or 4, wherein the plurality of ribs comprises a curved distal face. 6. Grip accessory according to claim 4 or 5, wherein the ribs provide a flared opening to the channel for guiding an unlatching surface into the channel. As an injection device,
The grip accessory of claim 1; And
Including a manual injection device, the manual injection device,
A syringe body having a needle at the proximal end;
A syringe sheath supporting the syringe body therein;
A safety shield, the safety shield being movable relative to the syringe sheath between a retracted position in which the needle extends from the proximal end of the safety shield and an extended position in which the safety shield extends over the needle;
A biasing element for biasing the shield toward an extended position of the shield;
A releasable locking mechanism for maintaining the syringe sheath in the retracted position of the syringe sheath against the bias of the biasing element, thereby preventing movement of the syringe shield relative to the syringe sheath. The releasable locking mechanism moveable from a first position and a second position that does not prevent movement of the safety shield relative to the syringe sheath; And
A plunger rod extending from the distal end of the syringe body to deliver a dose of medicament through the needle, the plunger moving proximally to allow the plunger rod to deliver a dose of drug. And an unlocking component for moving the releaseable locking mechanism from a locked position of the releaseable locking mechanism to an unlocked position of the releaseable locking mechanism. , Injection device. The method of claim 7, wherein
The releasable locking mechanism is at least one movable from a first position that allows the safety shield to remain in the retracted position of the safety shield and a second position that no longer holds the safety shield to the retracted position of the safety shield. Includes a deflectable latching arm of
And the plunger includes a latching element configured to move the at least one flexible latch arm from a first position of the flexible latch arm to a second position of the flexible latch arm. 8. The injection device of claim 7, wherein the latching element is a flange or disk extending from the plunger rod. 10. The injection device of claim 7, 8 or 9, wherein the channel is dimensioned to receive the latching element and to prevent lateral movement of the latching element with respect to the housing. The plunger rod of claim 7, wherein the plunger rod includes an actuating surface at the distal end of the plunger rod for receiving a thumb or finger of a user when delivering an injection. An injection device, dimensioned to receive a surface and to prevent lateral movement of the working surface relative to the housing. As a manual injection device,
A syringe housing for holding a syringe body having a discharge nozzle;
A safety shield, the safety shield being movable between a retracted position and an extended position in which the safety shield extends over a needle;
A convenience device for biasing said safety shield to an extended position of said safety shield;
Maintaining the safety shield in the retracted position of the safety shield when in the locked position and allowing the safety shield to move to an extended position of the safety shield under the influence of the comfort device when in the unlocked position Releasable locking mechanism; And
A plunger for delivering a dose of drug through the discharge nozzle, the plunger being movable from a distal position to a proximal position along a longitudinal axis, wherein the plunger,
An actuation surface at the distal end of the plunger, to which actuation force for moving the plunger along the longitudinal axis may be applied to deliver the dose of drug; And
And an unlocking element proximal to the operating surface configured to unlock the releasable locking mechanism to allow the safety shield to move to an extended position of the safety shield. 13. The method of claim 12, wherein the releasable locking mechanism has a first position that allows the safety shield to remain in a retracted position of the safety shield and a second that no longer holds the safety shield to the retracted position of the safety shield. At least one deflectable latching arm movable from a position,
The plunger moves the at least one flexible latch arm from a first position of the flexible latch arm to a second position of the flexible latch arm when the plunger is moved from a distal position of the plunger to a proximal position of the plunger. A manual injection device, configured to move. 14. The manual injection device of claim 12 or 13, wherein the latching element comprises an annular projection extending from the body of the plunger and spaced apart from the working surface of the plunger. The plunger of claim 12, wherein the plunger comprises a distal portion and a proximal portion,
The distal portion has a first cross-sectional diameter,
The proximal portion has a second cross-sectional diameter,
And the first cross-sectional diameter is greater than the second cross-sectional diameter, the distal end of the distal portion comprising the working surface and the proximal end of the proximal distal portion comprising an unlatching portion. 16. The passive injection device according to any one of claims 12-15, wherein the unlatching portion comprises a curved proximal surface. 17. The grip accessory of claim 12, wherein the grip accessory further comprises a retractable sheath, wherein the retractable sheath is provided with an extended position and discharge needle extending the sheath over the proximal end of the discharge nozzle. A manual injection device, movable between the retracted positions extending from the retractable sheath. 18. The grip accessory of claim 17, wherein the retractable sheath is retractable to a position where the proximal end of the retractable sheath does not extend from a plane defined by a skin contact surface. The grip accessory of claim 8, wherein the unlatching element is relatively more flexible than the distal end of the grip accessory housing.

Images